NCT05862246 Gastrocnemius Tightness and Foot Pain in Children
| NCT ID | NCT05862246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Olavs Hospital |
| Condition | Child Development |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-05-09 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Foot and leg pain among otherwise healthy children is a common reason for referral to our pediatric orthopaedics outpatient clinic. The pain is often intermittent and transient, but for some the pain is more dominating and has an impact on the child and families. Children grown and have normal anatomical variations such as in-toeing, out-toeing, hypermobility, flatfeet, knock knees etc. Assessing such normal variants is a major part of pediatric orthopaedic practice, and a common finding is a positive Silvferskiöld test, indicating gastrocnemius tightness. This is when dorsiflexion of the ankle is limited with extended knee, compared to flexed knee. We do not know if this is a more frequent finding among children with foot and leg pain. There is however evidence that adults with painful foot conditions often have gastrocnemius tightness. This project will investigate for gastrocnemius tightness in otherwise healthy children referred to our pediatric orthopaedic outpatient clinic with foot and leg pain, and compare results with a similar control group of children without pain. The aim is to investigate if there is an association, and how pain and tightness develops over time. The knowledge from this project will enable us to develop new treatment strategies to this patient group, where current evidence based recommendations are few.
Eligibility Criteria
Inclusion Criteria: * Otherwise healthy children referred to pediatric orthopaedic outpatient clinic with foot and/or leg pain with a normal leg function Exclusion Criteria: * Patients with foot conditions, general medical conditions affecting the foot or clinical findings indicating a need for further investigation for a diagnosis. Such as: Foot deformities (cavo-varus foot, clubfoot) Tarsal coalitions Neuro-orthopedic conditions (CP, MMC) Fracture sequelae Infections and tumour
Contact & Investigator
Håkon Langvatn
PRINCIPAL INVESTIGATOR
St. Olavs Hospital
Frequently Asked Questions
Who can join the NCT05862246 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 16 Years, studying Child Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05862246 currently recruiting?
Yes, NCT05862246 is actively recruiting participants. Contact the research team at tina.stromdal.wik@stolav.no for enrollment information.
Where is the NCT05862246 trial being conducted?
This trial is being conducted at Trondheim, Norway.
Who is sponsoring the NCT05862246 clinical trial?
NCT05862246 is sponsored by St. Olavs Hospital. The principal investigator is Håkon Langvatn at St. Olavs Hospital. The trial plans to enroll 200 participants.